Global Study Manager

Overview

Global Pharma seeks Global Study Manager in Early Hematology / Permanent / Home-based.

ICON plc is a world-leading healthcare intelligence and clinical research organization. We’re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development.

We are currently seeking a Senior Clinical Trial Manager (Global Study Manager) to join our diverse and dynamic team. As the Senior Clinical Trial Manager, you will hold a crucial role in ensuring the successful delivery of all clinical aspects of the studies. Your expertise and leadership will be instrumental in managing the clinical portion of the budget, developing effective monitoring plans, and driving enrollment to meet project objectives. Moreover, you will liaise with stakeholders, identify and mitigate risks, and provide comprehensive reporting on all clinical activities.

Responsibilities

• Recognize, exemplify and adhere to ICON's values which center on our commitment to people, clients and performance.
• As a Professional, recognize the importance of and create a culture of process improvement with a focus on streamlining processes, adding value to the business, and meeting client needs. Actively identify opportunities for process improvement. Lead or participate in process improvement initiatives, as assigned, and promote sharing of best practices.
• Contribute to the development of study documents as appropriate as well as any updates / amendments, ensuring template and version compliance.
• Lead the preparation of country specificagreements, confidentiality agreements, clinical trial applications and other applicable country documents.
• Manage the set-up of third-party vendors, assessing initial statement of work and budget, as well as the change order process.
• Provide input to data management documents (e.g., Case Report Form, Data Validation Specifications), and interface with data management representatives and site staff to facilitate the delivery of study data.
• Initiate contract / budget requests and track ongoing status; facilitate generation of purchase orders, review vendor invoices and assist in tracking spend against approved budget.
• Ensure the supply of Investigational product and study materials by liaising with Drug Supply or external service providers as appropriate.
• Oversight of third party vendors, global / local internal staff and investigators sites to support effective delivery of a study and its regulatory documents from development of the protocol through to the Clinical Study Report.
• Provide oversight and support recruitment and data delivery as well as risk mitigation strategies.
• Sustain up-set up, mainentance, closeout and archiving of the Trial Master File (TMF), ensuring continuity in inspection readiness.
• Prepare presentation material for meetings, newsletters and websites.
• Support the study team in the implementation of audits and regulatory inspections.
• Contribute to review of new / amended / unqiue SOPs and guidance documents.

Your profile

What ICON can offer you

Our success depends on the quality of our people. That’s why we’ve made it a priority to build a diverse culture that rewards high performance and nurtures talent.

In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family.

Our benefits examples include :

Visit our careers site to read more about the benefits ICON offers.

At ICON, inclusion & belonging are fundamental to our culture and values. We’re dedicated to providing an inclusive and accessible environment for all candidates. ICON is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.

If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know or submit a request here.

Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless - there’s every chance you’re exactly what we’re looking for here at ICON whether it is for this or other roles.

Are you a current ICON Employee? Please click here to apply

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